Nov. 2, 2018

FDA Makes Wrong Call; Super-Strong Opioid Medication Will Be Abused and Kill People

FDA Rigged Committee Vote to Ensure a Positive Recommendation

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) is recklessly and needlessly endangering people by approving a super-strong opioid, Public Citizen and the head of a key FDA advisory committee said today.

The FDA gave the green light for the medication, which is called sufentanil sublingual tablet (brand name Dsuvia) and is to be used to treat moderate-to-severe acute pain in a medically supervised setting. It is five to 10 times more potent than fentanyl and 1,000 times more potent than morphine.

“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group. “It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die. It is likely, if not certain, that that Dsuvia will be banned after ‘enough’ such deaths occur and the inevitable House oversight hearings are held investigating why the FDA approved this opioid with no unique benefit but unique harms.”

Public Citizen and Dr. Raeford Brown, chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, last month warned (PDF) the agency not to approve the medication. Brown’s public stance was highly unusual because he bucked his committee’s recommendation and publicly warned against approval.

Brown has described Dsuvia as so potent that abusers of the intravenous formulation of it – which has been available since 1984 for use by clinicians only in hospital settings for general anesthesia – often die when they inject the first dose. He said he has “witnessed this in resuscitating physicians, medical students, technicians and other health care providers, some successfully.”

“I am very disappointed with the decision of the agency to approve Dsuvia,” Brown said. “This action is inconsistent with the charter of the agency. As I discussed with representatives of the agency today, the lack of efficacy data and the sponsor’s inadequate response to safety concerns have not been addressed since the FDA’s complete response letter was sent in 2017. Clearly the issue of the safety of the public is not important to the commissioner, despite his attempts to obfuscate and misdirect. I will continue to hold the agency accountable for their response to the worst public health problem since the 1918 influenza epidemic.”

Despite FDA Commissioner Scott Gottlieb’s misleading statement today that “we routinely seek advisory committee input on new opioid product approvals,” the “committee review process was rigged,” Wolfe said.

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee last month recommended approving Dsuvia by a 10-3 vote (Brown was absent). But the meeting at which the committee considered the medication should have included the full Drug Safety and Risk Management Advisory (DSaRM) committee, of which Wolfe was a member from 2008 to 2012, Wolfe said.

In fact, the committee had been invited to a meeting last May to consider Dsuvia. However, in the late summer, the FDA disinvited all but three members, who participated in the October meeting, Wolfe said.

“By disinviting all but three members of the DSaRM, the FDA knew that would help get a positive vote for the medication,” he said.

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